Views of Cancer Patients Regarding Financial Conflicts of Interest
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00097682 |
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Recruitment Status :
Completed
First Posted : November 25, 2004
Last Update Posted : July 2, 2017
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Sponsor:
National Institutes of Health Clinical Center (CC)
Information provided by:
National Institutes of Health Clinical Center (CC)
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date | November 24, 2004 | ||
| First Posted Date | November 25, 2004 | ||
| Last Update Posted Date | July 2, 2017 | ||
| Study Start Date | November 18, 2004 | ||
| Primary Completion Date | Not Provided | ||
| Current Primary Outcome Measures | Not Provided | ||
| Original Primary Outcome Measures | Not Provided | ||
| Change History | |||
| Current Secondary Outcome Measures | Not Provided | ||
| Original Secondary Outcome Measures | Not Provided | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title | Views of Cancer Patients Regarding Financial Conflicts of Interest | ||
| Official Title | Ethics Study to Understand the Views of Cancer Patients Regarding Financial Conflicts of Interest in Research | ||
| Brief Summary | This study will explore what research patients understand about financial collaborations in the research setting and their concerns about these collaborations. Financial partnerships are crucial to advancing medical research; however, they are giving rise to increasing concerns about financial conflicts of interest and possible impacts on the integrity of research and patient safety. This study will examine patients' views about financial ties between drug companies and the doctors running research studies, as well as ties between the drug companies and the cancer centers where the studies are conducted. Patients 18 years of age and older who are enrolled in cancer studies at the National Cancer Institute in Bethesda, MD; the Fred Hutchinson Cancer Research Center in Seattle, WA; the Dana-Farber Cancer Institute in Boston, MA; the Columbia Comprehensive University Herbert Irving Cancer Center in New York, NY; and the University of Colorado Cancer Center in Denver, CO, may be eligible for this study. Participants are interviewed about the following:
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| Detailed Description | This study seeks to inform deliberation of ethical issues related to financial conflicts of interest in clinical research through empirical data obtained from patients participating in cancer studies. In particular, this study endeavors to describe and summarize the views of patients about both individual and institutional financial conflicts of interest pertaining to clinical research. This study will assess awareness of financial conflicts of interest and the current safeguards in place to manage financial ties; assess the impact of hypothetical financial conflicts of interest on a research subject's decision to participate in a clinical study; identify the reasons that financial conflicts of interest either do or do not influence patients' research participation; summarize views regarding the presence of financial conflicts of interest and what limits should be in place to manage them; identify interests about disclosure of these financial conflicts of interest; describe demographic characteristics of subjects enrolled in the survey and evaluate the impact of demographic information on subjects' views regarding financial conflicts of interest. Participants will be recruited from all phases of oncology studies being conducted at 5 sites, the National Cancer Institute in Bethesda, MD; the Dana-Farber Cancer Institute in Boston, MA; the Fred Hutchinson Cancer Research Center in Seattle, WA; the University of Colorado Cancer Center in Denver, CO, and the Columbia University Herbert Irving Comprehensive Cancer Center in New York, NY. The primary methodology for the study is an in-person administration of a questionnaire. | ||
| Study Type | Observational | ||
| Study Design | Not Provided | ||
| Target Follow-Up Duration | Not Provided | ||
| Biospecimen | Not Provided | ||
| Sampling Method | Not Provided | ||
| Study Population | Not Provided | ||
| Condition | Neoplasms | ||
| Intervention | Not Provided | ||
| Study Groups/Cohorts | Not Provided | ||
| Publications * | Kelch RP. Maintaining the public trust in clinical research. N Engl J Med. 2002 Jan 24;346(4):285-7. | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status | Completed | ||
| Enrollment |
300 | ||
| Original Enrollment | Same as current | ||
| Study Completion Date | October 2, 2007 | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria |
Subjects will be included if they:
EXCLUSION CRITERIA: None. |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number | NCT00097682 | ||
| Other Study ID Numbers | 050038 05-CC-0038 |
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| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | Not Provided | ||
| Study Sponsor | National Institutes of Health Clinical Center (CC) | ||
| Collaborators | Not Provided | ||
| Investigators | Not Provided | ||
| PRS Account | National Institutes of Health Clinical Center (CC) | ||
| Verification Date | October 2, 2007 | ||